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Gedatolisib Demonstrates Promising Efficacy in Phase 3 VIKTORIA-1 Trial for HR+/HER2- Advanced Breast Cancer: NDA Submission Initiated
Posted inOncology

Gedatolisib Demonstrates Promising Efficacy in Phase 3 VIKTORIA-1 Trial for HR+/HER2- Advanced Breast Cancer: NDA Submission Initiated

Posted by By MedXY 10/24/2025
Celcuity's phase 3 VIKTORIA-1 trial reveals that gedatolisib, a broad-spectrum PI3K/mTORC1/2 inhibitor, significantly improves progression-free survival in hormone receptor-positive, HER2-negative advanced breast cancer patients post CDK4/6 inhibitor therapy, prompting NDA rolling submission.
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